Protocol summary
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Study aim
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This study is designed to compare the pharmacokinetic and pharmacodynamic of Somatin® and Norditropin® in healthy volunteers.
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Design
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This randomized, single-dose, two-way, crossover study is conducted to compare the pharmacodynamic and pharmacokinetic of Somatin® and Norditropin® in 30 healthy adults volunteers. Volunteers will be sorted and receive a number from 1 to 30. In the first phase of the study, 15 volunteers will receive Somatin® produced by AryaTinaGene Biopharmaceutical Co. and the remaining 15 volunteers will receive Norditropin® produced by Novo Nordisk Co.The administered drugs will be replaced by each other in the second phase of the study.
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Settings and conduct
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The dose administration and subsequent sample collection will be performed in S. Motahhari hospital (Gonbade Kavous, Iran).
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Participants/Inclusion and exclusion criteria
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Volunteers,18-50 years of age. The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent. Good health at screening. Exclusion criteria: History of any drug hypersensitivity or intolerance. Significant history or current evidence of chronic disease. Receipt of any drug as part of a research study within 30 days prior to the present study.
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Intervention groups
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First intervention group: a single subcutaneous injection of Somatin (5 mg) manufactured by AryaTinaGene Biopharmaceutical Co. to 15 subjects. Second intervention group: A single subcutaneous injection of Norditropin (5 mg) manufactured by Novo Nordisk Co. to 15 subjects. Since in this study, the volunteers will receive both Test and Reference drugs, each volunteer will act as his own control.
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Main outcome variables
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Drug serum concentration; area under the serum concentration-time curve
General information
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Reason for update
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The English title was not revised
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130626013776N20
Registration date:
2020-03-28, 1399/01/09
Registration timing:
prospective
Last update:
2020-06-08, 1399/03/19
Update count:
1
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Registration date
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2020-03-28, 1399/01/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-20, 1399/02/01
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Expected recruitment end date
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2020-06-21, 1399/04/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Study of the pharmacokinetic and pharmacodynamic and safety properties of Somatin® (5 mg/1.5 ml cartridges, AryaTinaGene Biopharmaceutical Co) in comparison to Norditropin® (5 mg/1.5 ml cartridges, Novo Nordisk) in healthy volunteers
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Public title
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Bioequivalence Study of Somatropin in Healthy Human Volunteers
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Purpose
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Basic scienece
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Inclusion/Exclusion criteria
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Inclusion criteria:
Volunteers, 18-50 years of age.
The subject is able and willing to provide signed informed consent.
The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent.
The subject has stable residence and telephone.
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
Exclusion criteria:
History of allergy or sensitivity to somatropin.
History of any drug hypersensitivity or intolerance which, in the opinion of the investigator,would compromise the safety of the subject of the study.
Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
Presence of gastrointestinal disease or history of malabsorption within the last year.
History of a medical disorders occurring within the last year that required hospitalization or medication.
Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
Receipt of any drug as part of a research study within 30 days prior to the present study.
Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study.
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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Bioequivalence
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
16
A volume of 2 ml of blood is obtained in each sampling time through a venous cannula
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Each subject is identified by a number from 1 to 30. This number is allocated according to their entrance to volunteers' list in the screening day. Then, the following randomization table is used according to the crossover design of the study. All participants randomized into two sequences of Test/Reference and Reference/Test products
Subjects Dosing Sequence Day 1 Day 8
1 R/T Reference Test
2 T/R Test Reference
3 T/R Test Reference
4 R/T Reference Test
5 T/R Test Reference
6 R/T Reference Test
7 R/T Reference Test
8 T/R Test Reference
9 T/R Test Reference
10 T/R Test Reference
11 R/T Reference Test
12 R/T Reference Test
13 T/R Test Reference
14 T/R Test Reference
15 T/R Test Reference
16 R/T Reference Test
17 T/R Test Reference
18 R/T Reference Test
19 R/T Reference Test
20 R/T Reference Test
21 T/R Test Reference
22 T/R Test Reference
23 R/T Reference Test
24 R/T Reference Test
25 R/T Reference Test
26 R/T Reference Test
27 T/R Test Reference
28 T/R Test Reference
29 T/T Test Reference
30 R/T Reference Test
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-09, 1398/12/19
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Ethics committee reference number
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IR.GOUMS.REC.1398.352
Health conditions studied
1
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Description of health condition studied
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.
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Serum concentration of somatropin, IGF-1 and IGFBP-3
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Timepoint
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−1.0, −0.5, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours after injection
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Method of measurement
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Blood sampling and measurement of serum concentrations by chemiluminescence immunoassay
2
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Description
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Area under serum concentration-time curve
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Timepoint
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−1.0, −0.5, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours after injection
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Method of measurement
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Blood sampling and measurement of serum concentrations by chemiluminescence immunoassay
Secondary outcomes
1
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Description
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Time to reach maximum serum concentration
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Timepoint
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Sampling at times of 1, 2, 3, 4 and 6 hours after injection
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Method of measurement
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From serum concentration-time curve
2
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Description
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Serum half-life
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Timepoint
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From the terminal 84 hours of serum concentration-time profile
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Method of measurement
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Blood sampling and measurement of serum concentrations by chemiluminescence immunoassay
Intervention groups
1
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Description
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Intervention group: A subcutaneous injection of a single dose of 5 mg of Somatin produced by AryaTinaGene Biopharmaceutical Co. to healthy volunteers
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Category
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Treatment - Drugs
2
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Description
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Intervention group: A subcutaneous injection of a single dose of 5 mg of Norditropin produced by Novo Nordisk Co. to healthy volunteers.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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AryaTinaGene Biopharmaceutical Co
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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AryaTinaGene Biopharmaceutical Co
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Data are confidential and need permission from the company.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available